药物临床试验数据失真性辨析

Analysis on nauthentic data in new drug clinical trials

临床试验数据的真实性与准确性是极其重要的,任何失真性数据都可能影响临床试验结果,造成不可弥补的损失。笔者认为临床试验失真性数据,即包括主观造假的数据,也包括客观形成的不准确数据。笔者通过对临床试验失真性数据的一系列特征表述,探讨了辨识方法,并分析、归纳其产生的原因。这些原因包括对试验结果的主观干预、研究者GCP知识水平参差不齐、研究者对试验方案的理解与认识误差等。最终提出通过加强研究者及相关人员的科研素质教育、加强数据采集过程质量控制等手段来防止临床试验失真性数据产生的对策与建议。

The authenticity and accuracy of data in clinical trials is extremely important. Any inauthentic data may affect the result of a clinical trial, and cause great loss. In our opinion, inauthentic data includes not only man-made spurious data, but also inaccurate data objectively formed. In this article, the features of inauthentic data are described, how to distinguish inauthentic data is discussed, and the causes of this kind of data are analyzed and concluded, which include ： subjective intervention on the result of clinical trials, differentiation of the GCP knowledge level between different investigators, misunderstanding of the protocol, et al. And finally we propose that scientific training to investigators and other involved personnel and quality control during the course of data collection should be strengthened to prevent the occur of inauthentic data in clinical trials.